Clinical Research Associate | Hybrid

Sonova
United States
Workplace: HybridFull timeUSD 72,000 - 90,000Function: Research & Scientific (R&D)Experience: 2+ yearsEducation: bachelorsSkills: ["Organizational skills","Communication skills","Problem-solving","Time management","Independent prioritization","Risk escalation"]

Manage end-to-end execution of global medical device clinical studies—from site start-up and qualification through interim monitoring and close-out. Serve as the primary operational contact for assigned investigative sites, monitoring performance, enrollment, protocol compliance, and data quality while escalating risks and ensuring resolution of monitoring findings and queries. Maintain inspection-ready clinical documentation (TMF/eTMF) and support audits, regulatory submissions, and cross-functional study execution.

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FursaFursa
Sonova
Sonova
12 hours ago

Clinical Research Associate | Hybrid

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Source: Company careers pageValidated by: Fursa AI
Last checked: 12 hours agoStatus: Live

Job Summary

Manage end-to-end execution of global medical device clinical studies—from site start-up and qualification through interim monitoring and close-out. Serve as the primary operational contact for assigned investigative sites, monitoring performance, enrollment, protocol compliance, and data quality while escalating risks and ensuring resolution of monitoring findings and queries. Maintain inspection-ready clinical documentation (TMF/eTMF) and support audits, regulatory submissions, and cross-functional study execution.
Location: United States
Workplace: Hybrid
Employment Type: Full time
Job Function: Research & Scientific (R&D)
Seniority: Mid level

Key Responsibilities

  • •Execute clinical studies from site start-up through study close-out in compliance with protocols, ICH-GCP, ISO 14155, FDA regulations, and applicable requirements.
  • •Perform site qualification, initiation, interim monitoring, and close-out visits (SQV, SIV, IMV, COV).
  • •Support site activation, investigator training, study device accountability, and study close-out activities.
  • •Act as the primary operational contact for assigned investigative sites, monitoring performance, enrollment, protocol compliance, and data quality.
  • •Maintain accurate, inspection-ready clinical documentation (TMF/eTMF and investigator site files) and support audits and regulatory inspections.
Travel: High travel

Pay and Benefits

Salary: USD 72,000 - 90,000
Perks:Health InsuranceDentalVision401kLife InsuranceDisability InsurancePaid LeaveParental LeavePaid Holidays

Key Requirements

  • •Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering, or a related scientific discipline.
  • •Minimum 2 years of clinical research experience, including at least 1 year of independent site monitoring.
  • •Experience managing multiple clinical sites and working with CTMS, EDC, and eTMF systems.
  • •Strong knowledge of ICH-GCP, ISO 14155, FDA regulations, clinical monitoring, site management, and data quality.
  • •Fluent English communication skills (written and spoken).
Experience:2+ yearsMedical devicesClinical research
Education:Bachelor's
Skills:Organizational skillsCommunication skillsProblem-solvingTime managementIndependent prioritizationRisk escalation
Certifications:ACRP-CRAACRP-CPSOCRA CCRP
Languages:English
Tech Stack:CTMSEDCETMFTMF

Company Brief

Sonova
Designs, manufactures, and distributes hearing care solutions including hearing aids, cochlear implant accessories, and wireless communication devices, serving audiologists and consumers worldwide through clinics, retail networks, and distribution partners.
Industry: Medical Devices
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Stäfa, Switzerland
Founded: 1947
Website